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灵北抑郁症重磅药物Trintellix(vortioxetine)获加拿大卫生部批准

来源:生物谷 2014-10-30 14:42

2014年10月27日讯 /生物谷BIOON/ --灵北(Lundbeck)近日宣布,加拿大卫生部已批准Trintellix(vortioxetine)用于重度抑郁症(MDD)成人患者的治疗。在加拿大,成人群体(18岁及以上)中MDD的发病率超过10%,女性群体发病率约为男性群体的2倍。业界此前预测,到2022年,该药在全球主要市场中将成为重磅药物,同时将成为单相抑郁症市场最成功的新药。

在美国,FDA于2013年9月批准vortioxetine,商品名为Brintellix,该药可供使用的规格包括5mg、10mg、25mg片剂,可解决重度抑郁症患者的不同需求。vortioxetine的获批,是基于一项全面临床开发项目中治疗重度抑郁症的疗效和安全性数据。该项目由7个关键性研究组成,包括6个为期6-8周的短期研究,以及1个为期24-64周的长维持性研究,这些研究结果表明,vortioxetine对重度抑郁症成人患者整体抑郁症状具有统计学意义的显著改善。

此前,全球领先的制药与医疗保健问题研究和咨询公司——决策资源公司(Decision Resources)发布报告预测,到2022年,Brintellix在美国、日本、欧盟五大主要市场(法国、德国、意大利、西班牙、英国)中将成为重磅药物。根据迄今取得的数据,鉴于其对认知的积极影响及可耐受的副作用属性,Brintellix预计将成为单相抑郁症市场中最成功的新药。(详见《单相抑郁症市场下个10年预测:灵北-武田Brintellix将成为重磅药物》

vortioxetine是一种新颖的5-羟色胺(5-HT)再摄取抑制剂,该药同时也是5-HT 1A受体激动剂、5-HT 1B受体部分激动剂,以及5-HT3、5-HT1D、5-HT7受体拮抗剂。目前,vortioxetine确切的抗抑郁作用机理尚不完全清楚。

重度抑郁症(MDD)通常被称为抑郁,是一种精神疾病,其特点是有情绪变化及其他症状,能干扰一个人的工作能力、睡眠、学习、饮食和享受愉快的活动。抑郁症的发作通常伴随人的一生,虽然有些人可能仅经历一次。该病的其它体征和症状包括对日常活动失去兴趣、体重或饮食发生明显变化、失眠或嗜睡、坐立不安/来回走动(激越)、疲劳、罪恶感或无价值感、思维迟缓、注意受损、自杀未遂或自杀想法。并非所有MDD患者均经历相同的症状。(生物谷Bioon.com)

英文原文:Lundbeck Canada Inc. Announces Health Canada Approval of Trintellix? (vortioxetine hydrobromide) for Treatment of Adults with Major Depressive Disorder

MONTREAL, Oct. 28, 2014 /CNW/ - Lundbeck Canada Inc. announced today that Health Canada has approved TrintellixTM (vortioxetine hydrobromide) for the treatment of major depressive disorder (MDD), a debilitating mental health illness which affects more than 1 in 10 Canadians over the age of 181 and occurs about twice as often in women than in men1,2,3.

"MDD manifests itself through a wide array of emotional, physical and cognitive symptoms. Beyond the mood component, changes in appetite and psychomotor activity, difficulty concentrating and making decisions, or even suicidal behaviour, are common. These symptoms can be felt by sufferers on a daily basis, often throughout the day, and seriously impede their ability to function" says Dr. Roger McIntyre, Full Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network. "With such a diverse group of symptoms, it is important to find diversity in treatment to improve patient outcomes."

About TrintellixTM

Trintellix is a novel agent indicated for the treatment of major depressive disorder (MDD) in adults. Trintellix is an inhibitor of serotonin (5-HT) reuptake and also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The efficacy of Trintellix in providing symptomatic relief of MDD was demonstrated in controlled clinical trials. The efficacy of Trintellix in maintaining an antidepressant response for up to 24 weeks was demonstrated in a controlled trial in patients with MDD who initially responded to an acute, open label treatment with Trintellix.4

"One can hope for better management of MDD symptoms, or one can act," says Patrick Cashman, President and General Manager of Lundbeck Canada Inc. "With the approval of Trintellix by Health Canada, we strive to offer new alternatives to Canadian patients living with MDD who deserve better treatment. This is why we keep pushing boundaries, trying to improve the daily lives of people who live with mental illness."

Trintellix will be made available in Canada by December 2014.

Burden of Depression

According to The World Health Organization, fewer than half of people with depression worldwide are receiving treatment5, and the burden of depression is expected to continue to rise globally6. For those who do seek treatment, discontinuation is not uncommon7,8. MDD is a heterogeneous disorder that does not consistently respond to therapy, thus it's important for patients to work with a healthcare provider to help find a treatment plan that works for them9.

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